NDC 52959-812

Phentermine Hydrochloride

Phentermine Hydrochloride

Phentermine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Phentermine Hydrochloride.

Product ID52959-812_4dac9654-cf35-4ad6-ba88-ccabe84069b0
NDC52959-812
Product TypeHuman Prescription Drug
Proprietary NamePhentermine Hydrochloride
Generic NamePhentermine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-10-23
Marketing CategoryANDA / ANDA
Application NumberANDA040527
Labeler NameH.J. Harkins Company, Inc.
Substance NamePHENTERMINE HYDROCHLORIDE
Active Ingredient Strength38 mg/1
Pharm ClassesAppetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA ScheduleCIV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52959-812-90

90 TABLET in 1 BOTTLE (52959-812-90)
Marketing Start Date2003-10-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-812-11 [52959081211]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-10-23
Inactivation Date2019-11-13

NDC 52959-812-45 [52959081245]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA203068
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-18
Inactivation Date2020-01-31

NDC 52959-812-20 [52959081220]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-10-23
Inactivation Date2019-11-13

NDC 52959-812-90 [52959081290]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-10-23
Inactivation Date2019-11-13

NDC 52959-812-14 [52959081214]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-10-23
Inactivation Date2019-11-13

NDC 52959-812-30 [52959081230]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-10-23
Inactivation Date2019-11-13

NDC 52959-812-10 [52959081210]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-10-23
Inactivation Date2019-11-13

NDC 52959-812-21 [52959081221]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA203068
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-18
Inactivation Date2020-01-31

NDC 52959-812-60 [52959081260]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-10-23
Inactivation Date2019-11-13

NDC 52959-812-28 [52959081228]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040527
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-10-23
Inactivation Date2019-11-13

NDC 52959-812-22 [52959081222]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-10-23
Inactivation Date2019-11-13

NDC 52959-812-07 [52959081207]

Phentermine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA040527
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-10-23
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
PHENTERMINE HYDROCHLORIDE37.5 mg/1

OpenFDA Data

SPL SET ID:a894c87a-f04d-4080-a52b-b3fd8b8b6e01
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 803353

    • Pharmacological Class

    • Appetite Suppression [PE]
    • Increased Sympathetic Activity [PE]
    • Sympathomimetic Amine Anorectic [EPC]

    NDC Crossover Matching brand name "Phentermine Hydrochloride" or generic name "Phentermine Hydrochloride"

    NDCBrand NameGeneric Name
    0185-0644phentermine hydrochloridephentermine hydrochloride
    0185-0647phentermine hydrochloridephentermine hydrochloride
    0185-5000phentermine hydrochloridephentermine hydrochloride
    0527-0597Phentermine HydrochloridePhentermine Hydrochloride
    0527-1308Phentermine HydrochloridePhentermine Hydrochloride
    0527-1310Phentermine HydrochloridePhentermine Hydrochloride
    0527-1438Phentermine HydrochloridePhentermine Hydrochloride
    0527-1445Phentermine HydrochloridePhentermine Hydrochloride
    0527-1742Phentermine HydrochloridePhentermine Hydrochloride
    0527-1743Phentermine HydrochloridePhentermine Hydrochloride
    10544-098Phentermine HydrochloridePhentermine Hydrochloride
    10544-099Phentermine HydrochloridePhentermine Hydrochloride
    10544-116Phentermine HydrochloridePhentermine Hydrochloride
    10544-552Phentermine HydrochloridePhentermine Hydrochloride
    10544-592Phentermine HydrochloridePhentermine Hydrochloride
    10544-593Phentermine HydrochloridePhentermine Hydrochloride
    10544-602Phentermine HydrochloridePhentermine Hydrochloride
    10544-620Phentermine HydrochloridePhentermine Hydrochloride
    10702-025Phentermine HydrochloridePhentermine Hydrochloride
    10702-026Phentermine HydrochloridePhentermine Hydrochloride
    10702-027Phentermine HydrochloridePhentermine Hydrochloride
    10702-028Phentermine HydrochloridePhentermine Hydrochloride
    10702-029Phentermine HydrochloridePhentermine Hydrochloride
    10702-067Phentermine HydrochloridePhentermine Hydrochloride
    11534-157Phentermine Hydrochloridephentermine hydrochloride
    11534-159Phentermine hydrochloridephentermine hydrochloride
    68071-3241Phentermine HydrochloridePhentermine Hydrochloride
    68382-670Phentermine HydrochloridePhentermine Hydrochloride
    68382-703Phentermine HydrochloridePhentermine Hydrochloride
    68382-704Phentermine HydrochloridePhentermine Hydrochloride
    68387-690Phentermine HydrochloridePhentermine Hydrochloride
    68788-8950Phentermine HydrochloridePhentermine Hydrochloride
    68788-8942Phentermine HydrochloridePhentermine Hydrochloride
    68788-9271Phentermine HydrochloridePhentermine Hydrochloride
    69677-293Phentermine HydrochloridePhentermine Hydrochloride
    70771-1201Phentermine HydrochloridePhentermine Hydrochloride
    70771-1202Phentermine HydrochloridePhentermine Hydrochloride
    70771-1200Phentermine HydrochloridePhentermine Hydrochloride
    71335-0350Phentermine HydrochloridePhentermine Hydrochloride
    71335-0646Phentermine hydrochloridePhentermine hydrochloride
    71335-0419Phentermine HydrochloridePhentermine Hydrochloride
    71335-0564Phentermine HydrochloridePhentermine Hydrochloride
    71335-0678Phentermine HydrochloridePhentermine Hydrochloride
    71335-0474Phentermine HydrochloridePhentermine Hydrochloride
    71335-0030Phentermine HydrochloridePhentermine Hydrochloride
    71335-0161Phentermine HydrochloridePhentermine Hydrochloride
    75921-025Phentermine HydrochloridePhentermine Hydrochloride
    11534-176Phentermine HydrochloridePhentermine Hydrochloride
    11534-160Phentermine hydrochloridePhentermine hydrochloride
    12634-516Phentermine HydrochloridePhentermine Hydrochloride
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